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Clinical Trial Details

Trial ID: L1611
Source ID: NCT06795698
Associated Drug: Enoxaparin
Title: The Effect of Prophylactic Anticoagulation on Major Bleeding Events in Hospitalized Chronic Kidney Disease and Lower Limb Fracture Patients.
Acronym: FAA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Fractures, Bone|CKD Stage 4|CKD Stage 3|CKD Stage 5|Enoxaparin Adverse Reaction|Anticoagulant-induced Bleeding|Thromboses, Venous
Interventions: DRUG: Enoxaparin
Outcome Measures: Primary: Major bleeding, Number of Participants with Major bleeding were defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria (Schulman S). Defined as the composed event of: 1- Fatal bleeding, and/or; 2- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3- Bleeding causing a fall in hemoglobin level of 2.0 g/dL or more, or leading to transfusion of two or more units of whole blood or red cells, From date of randomization until the date of first documented major bleeding or death from any cause, whichever came first up to 20 days. From date of randomization until surgery. Pre-intervention/procedure/surgery. | Secondary: Thrombosis, Number of Participants with Thrombosis was defined as the occurrence of a definite or probable venous thromboembolism (VTE) event. As deep vein thrombosis (DVT) typically presents with pain, swelling, warmth, or erythema of the affected limb, From date of randomization until the date of first documented thrombosis, or date of death from any cause, whichever came first, assessed from date of randomization until surgery up to 20 days. Pre-intervention/procedure/surgery.|Dead, Number of Participants dead, through study completion, an average of 3 weeks|number of transfusions, Number of transfusions presurgery, From date of randomization until the date of first documented transfusions and number of transfusions. Pre-intervention/procedure/surgery.|acute kidney injury, Number of Participants with acute kidney injury, defined as an increses in serum creatinine \>0.3mg/dL during 48 hours period, From date of randomization until the date of first documented acute kidney injury up to 20 days. From date of randomization until surgery. Pre-intervention/procedure/surgery.|hospitalization days, number of days in hospital., number of days in hospital. through study completion, an average of 3 weeks
Sponsor/Collaborators: Sponsor: Hospital Civil de Guadalajara
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 61
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-03-01
Completion Date: 2024-12-01
Results First Posted:
Last Update Posted: 2025-01-28
Locations: Hospital Civil de Guadalajara, Guadalajara, Jalisco, 44240, Mexico
URL: https://clinicaltrials.gov/show/NCT06795698